The Impact of Fitness and Mineralocorticoid Receptor Blockade on Vascular Dysfunction in Adults With Type 1 Diabetes
Completed · Not applicable
Conditions studied: Type 1 Diabetes
In brief
In this protocol, 60 subjects with DM1 will be studied at baseline, after 12 weeks of MCR blockade or 12 weeks of exercise, and again after an additional 12 weeks of MCR blockade, exercise or the combination of both interventions. The investigators will assess function in conduit (pulse wave velocity-PWV, flow-mediated dilation-FMD and augmentation index-AI), resistance (post-ischemic flow velocity-PIFV) and heart and skeletal muscle microvascular (contrast enhanced ultrasound-CEU) vessels before and after 2 hrs of a euglycemic insulin clamp. We hypothesize that compared to healthy controls, both baseline and insulin-responsive vascular function are impaired throughout the arterial vasculature by DM1 and that exercise training and/or mineralocorticoid receptor (MCR) blockade will improve both baseline and insulin-responsive pan-arterial function.
Key facts
- Study ID
- NCT03174288
- Run by
- University of Virginia
- People needed
- 32
- Starts
- 2015-08-01
- Expected to finish
- 2019-05-22
- Last updated by the study team
- 2019-12-18
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age 18-50 years
- BMI ≤30
- No clinically significant lab values other than those consistent with DM1
- Subjects will have been on insulin for at least 5 years and HbA1c <9
You may not qualify if…
- Smoking presently or in the past 6 months
- Medications that affect the vasculature (except ACE or ARB , although they will need to be off these drugs for 2 weeks prior to study).
- Elevated LDL cholesterol > 160
- BP <100/60 or >160/90
- Pulse oximetry <90%
- Pregnant or breastfeeding
- History of cardiovascular disease, cerebral vascular disease, peripheral vascular disease, liver disease
- Presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam).
- Known hypersensitivity to perflutren (contained in Definity)
- Serum Potassium ≥5.0
- HbA1c ≥ 9
- Retinopathy
- Ketoacidosis within the past year.
Where it is running
- University of Virginia — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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